Status:
COMPLETED
Phenylephrine for Spinal Induced Hypotension
Lead Sponsor:
IWK Health Centre
Conditions:
Hypotension
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
This study is designed to determine the ED90 for a single dose of phenylephrine for the treatment of spinal induced hypotension in parturients presenting for an elective CD. The ED90 is the effective ...
Eligibility Criteria
Inclusion
- Non-emergent cesarean delivery with planned regional anesthesia (i.e. elective planned cesarean delivery for malposition, patient choice, cervical pelvic disproportion, previous cesarean delivery and other diagnosis that require a predetermined cesarean delivery)
- American Society of Anesthesia physical status class I \& II (ASA I - Healthy, ASA II - mild and controlled systemic disease, eg. controlled essential hypertension)
- Age ≥ 18 years (Standard within the obstetrical literature)
- Term gestational age
- English-speaking
Exclusion
- Morbid Obesity (Body Mass Index ≥ 45 kg/m2) (Morbidly obese parturients require a dose of local anesthetic less than the standardized dose in this study, typically have an exaggerated response to vasopressors, and the blood pressure cuff occasionally needs to be replaced by an intraarterial catheter due to limitations in size)
- Height \< 5'0" (Women \< 5'0" are likely to require a dose of local anesthetic less than the standardized dose in this study)
- Laboring women
- Urgent or emergency cesarean delivery
- Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP) \> 160mmHg, diastolic blood pressure (DBP) \> 110mmHg and/or requiring antihypertensive treatment or associated with significant proteinuria
- Severe maternal cardiac disease
- Diabetes type I
- Subjects on monoamine oxidase inhibitors (MAOI's) or tricyclic antidepressants
- Fetal anomalies
- Failed spinal anesthesia
- Subject enrollment in another study involving a study medication within 30 days of CD
- Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00781157
Start Date
January 1 2008
End Date
October 1 2008
Last Update
May 23 2013
Active Locations (1)
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1
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8